Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00580970
First received: December 20, 2007
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer


Condition Intervention Phase
Prostate Cancer
Drug: lovastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Toxicity to the rectum within the first two years of radiation treatment [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 53
Study Start Date: April 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Lovastatin + radiation therapy
Drug: lovastatin
20 mg/day for 12 months

Detailed Description:

Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
  • Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
  • Age at least 18 years
  • Karnofsky Performance Status (KPS) ≥ 70
  • No history of prior radiotherapy to the prostate or rectum
  • History of prior malignancy, if likely to live at least 4 years, is acceptable.
  • No evidence of distant metastases
  • Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
  • Creatine kinase < 5 times upper normal limit
  • Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
  • transaminases < 3 times upper normal limit

Exclusion Criteria:

  • Planned abdomino-perineal resection after radiotherapy
  • Contraindication to an HMG-coA-reductase inhibitor
  • Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
  • Currently taking an inhibitor of cytochrome P450 3A4
  • Active liver or muscle disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580970

Locations
United States, Virginia
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, United States, 23249
Southside Regional Medical Center
Richmond, Virginia, United States, 23805
Sponsors and Collaborators
Virginia Commonwealth University
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
Principal Investigator: Mitchell S. Anscher, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00580970     History of Changes
Other Study ID Numbers: MCC-10802
Study First Received: December 20, 2007
Last Updated: September 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
prostate cancer
radiation therapy
lovastatin
rectal injury

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lovastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014